Feasibility and Acceptability of a Complex Intervention to Improve Initial Medication Adherence

Fundació Sant Joan de Déu

Status: Completed

Conditions: Adherence, Medication

Treatments: Other: Usual Care; Behavioral: Initial Medication Adherence (IMA) Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05094986

19/198-P

Details and patient eligibility

About

This pilot study aims to test the feasibility of the following effectiveness and cost-effectiveness evaluation using Real-World Data.

Full description

A cluster non-randomised pilot study with an embedded process evaluation was carried out to test the feasibility of the definitive cluster randomised controlled trial (cRCT). The cRCT will aim to evaluate the effectiveness and cost-effectiveness of the Initial Medication Adherence (IMA) intervention in comparison to usual care, to increase initiation of pharmacological treatments for CVD and diabetes (antihypertensive drugs, hypolipidemic drugs, antiplatelet drugs, and insulin and oral antidiabetics) prescribed in Primary Care (PC).

The pilot study was conducted in five PC centres (PCC) in Catalonia (Spain), two were assigned to the control group and three to the intervention group. There were two target participants, the implementation targeted professionals (general practitioners (GP), nurses, and community pharmacists), and the population targeted by the intervention, PC patients.

The IMA intervention provided healthcare professionals with the knowledge, skills, and tools to help the patient make an informed and shared decision with the GP to initiate a new CVD or diabetes treatment. Professionals were trained on the problem of non-initiation, communication skills, health literacy, and the use of decision aids (leaflets, website).

Enrollment: 605 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Primary healthcare professionals and pharmacists who:

• Agree to participate in the pilot study.

Primary care patients who:

• Are prescribed a new treatment of cardiovascular disease o diabetes by a GP who participates in the clinical trial.
• Are >18 years old.
• Do not reject to participate.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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605 participants in 2 patient groups

Intervention group: IMA Intervention

Experimental group

Description:

General practitioners (GP) applied the IMA intervention to all patients receiving a new prescription for pharmacological treatments of cardiovascular disease or diabetes. Following the IMA intervention, nurses and community pharmacists offered information support in line with the information provided by the GP. Professionals had the intervention support tools available (leaflets, website and dispensing alert in community pharmacies).

Treatment:

Behavioral: Initial Medication Adherence (IMA) Intervention

Control group

Active Comparator group

Description:

Healthcare professionals from the control group prescribed medication and provided information as usual.

Treatment:

Other: Usual Care